Monday, October 19, 2015

Nocera and Myers Hit Nail on the Head: FDA Should be "Pilloried" for Forcing E-Cigarette Companies to Hide the Truth from Consumers

New York Times columnist Joe Nocera and Campaign for Tobacco-Free Kids' director Matt Myers have hit the nail on the head. In an incisive Timescommentary last Friday, Nocera insightfully digs down to expose the core problem regarding the government's and the anti-smoking movement's treatment of electronic cigarettes: The anti-smoking groups' have confused the public about the relatively safety of e-cigarettes compared to smoking, and the government (is poised to) prohibit the e-cigarette companies from correcting this fallacy. As a result, rather than promoting their products based on their main benefit (being much safer than cigarettes and not containing any tobacco), they are left to market their products in ways that might appeal to youth (as a sexy, cool, digital alternative tobacco product). And Myers adds that it is the FDA's fault for sitting by for six years and allowing this situation to get out of control.

Nocera writes: "Two
weeks ago, I received an email from NJOY, a company that sells
electronic cigarettes. Its purpose was to introduce the Daily, a new
product that NJOY described as “a superior e-cigarette scientifically
developed to deliver quick-and-strong nicotine satisfaction at levels
close to an actual cigarette.”An
e-cigarette that could truly replicate the experience of smoking would
dramatically reduce — not eliminate, but reduce — the dangers of
smoking. NJOY claims that the Daily comes closer to that experience than
anything on the market." ...

"I thought to myself, “The
tobacco-control community is going to hate this thing.” Most
anti-tobacco advocates view replicating the feel and satisfaction of a
cigarette as an effort to “renormalize smoking.” And though some believe
that smokers should be encouraged to move to e-cigarettes, most refuse
even to acknowledge the health benefits of “vaping” over smoking. Indeed,
thanks to this vociferous opposition, an increasing number of Americans
view vaping as no safer than smoking, which is absurd. And e-cigarette
manufacturers like NJOY can’t set them straight: The law giving the Food
and Drug Administration regulatory authority over tobacco products,
which passed in 2009, prohibits e-cigarette companies from making
reduced-harm claims unless they jump through some near-impossible hoops.
Thus, NJOY has no way to convey to adult smokers the critical message
that e-cigarettes could save their lives." ...

"One thing that particularly bothers Myers about e-cigarette companies is
their advertising, which he believes employs the same tactics Big
Tobacco once used to hook youths on cigarettes. But when I noted that
NJOY can’t market the Daily as a reduced-risk product, thanks to the
2009 law — and thus had to find less straightforward ways to induce
smokers to try the product — Myers told me that I should blame the
F.D.A., which, six years in, has yet to impose a single regulation on
e-cigarettes. “I think the F.D.A. deserves to be pilloried,” he said."

The Rest of the Story

This is a critical commentary, and I'm glad that it received prominent attention in the New York Times. It exposes what I think is the most serious problem regarding the treatment of e-cigarettes, by both the anti-tobacco movement and the government.

The anti-tobacco movement's treatment of e-cigarettes has been a public health disaster because the overwhelming majority of the movement has misled the public into believing that vaping is just as harmful as smoking. Most health groups have failed to acknowledge that e-cigarettes have helped thousands of smokers to quit and that these devices have improved the health of tens of thousands because they are so much safer than tobacco cigarettes. This campaign of deception has been successful: the public is completely confused about the relative safety of real and fake cigarettes. And the campaign has been damaging: the public's appreciation of the severe hazards of smoking has been undermined, and quitting has largely been discouraged.

The FDA's treatment of e-cigarettes has also been a public health disaster. By vowing to regulate e-cigarettes in the same way as tobacco cigarettes, the agency has effectively precluded e-cigarette companies from telling the public the truth about their products and thereby mitigating the lies coming out of the anti-tobacco community. There are three major problems:

First, by subjecting e-cigarettes to the modified risk provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the truth: that e-cigarettes are much safer than tobacco cigarettes. Despite the lies coming out of many anti-tobacco groups, there is no dispute in the scientific community that this is factually accurate. Even Stan Glantz acknowledges this basic fact. But by subjecting e-cigarettes to section 911, the FDA would prohibit companies from telling the public this basic truth.

Second, by subjecting e-cigarettes to the reduced exposure provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the most important piece of consumer information about these products: that they do not contain any tobacco. Why? Because such a claim would be considered a reduced risk claim, which cannot be made without FDA authorization. And to get that authorization, an e-cigarette company would have to demonstrate that making the claim would not lead smokers to think that e-cigarettes are safer than tobacco cigarettes. But that is obviously impossible. Moreover, it would defeat the whole purpose of making the claim. Thus, it is a de facto ban on e-cigarette companies telling consumers that their product is free of tobacco.

Third, by disallowing companies to market their products based on their real and intended benefits (their relative safety compared to smoking), the FDA has left the companies with no choice other than to promote these products based on features like sexiness, glamour, coolness, and popularity, which cause this marketing to appeal to young people. In contrast, if the e-cigarette companies could market these products as a crutch for smokers who cannot break their addiction without going through the actual motions of smoking, their marketing would be a whole lot less appealing to youth. After all, kids aren't exactly running out the door to purchase over-the-counter smoking cessation products which deliver plenty of nicotine.

Nocera and Myers are correct that it is the FDA's fault. By simply issuing a regulation or even an advisory that e-cigarettes will not be subject to section 911, this problem could have been averted.

In fact, it is not too late. The only error in Nocera's column is the statement that the 2009 Tobacco Act prohibits the e-cigarette companies from making reduced risk claims. The 2009 law doesn't itself apply to e-cigarettes. However, as we know, the FDA will soon issue deeming regulations that will apply the 2009 law to e-cigarettes. And the proposed regulations made it clear that the agency's intent is to apply section 911 - the modified risk provisions - to e-cigarettes and vaping devices.

But the FDA does not have to take this action. Instead, it could carve out a separate regulatory framework for e-cigarettes by releasing them from adherence to section 911. The FDA could decide that telling consumers the truth about e-cigarettes is to the great benefit of the public's health, and that applying section 911 to these products is therefore unwarranted. The FDA could also recognize that prohibiting e-cigarette companies from telling the truth about their products is likely a violation of the free speech rights of the companies and could likely be successfully challenged in court.

It is now only a matter of weeks, or months, before we find out how the FDA decided to handle e-cigarettes. My hope, of course, is that it chose to exempt e-cigarettes from section 911. However, based on the proposed deeming regulations, it does not look like that is likely to be the case.

No comments:

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.